Rheumatic, connective tissue or ischemic heart diseases may heavily affect the configuration of the atrioventricular heart valves. Diseased valves may become narrow, incompetent or both. A great many patients suffering from ischemic heart disease, who previously underwent myocardial infarctions, consequently develop various degrees of mitral valve incompetence. Typically in those patients, the valve may grossly seem to be normal; yet its annulus is dilated, causing coaptation (i.e. interengagement) of the leaflets to be disturbed and resulting in incompetence of the valve. Such patients should benefit from an annuloplasty as a repair.
Annuloplasty rings have now generally become essential components of reconstructive surgery of the mitral and tricuspid valves. Their safety and durability have been proven in numerous clinical studies that have occurred since their genesis in the late 1960's. Subsequent experimental and clinical echocardiographic studies showed that the mitral and tricuspid annuli change continuously in size and shape during the cardiac cycle. Flexible rings were developed that could adapt to such changes. Although such flexible rings may avoid constraining the natural flexibility of the native annulus while still improving valve function, there are some disadvantages in using flexible as well as non-flexible, rigid rings. For example, when the suture spacing along the annulus is not matched to the spacing on the ring, tension in the tissue may result and cause tissue puckering or tearing. Thus, it is not yet proved that flexible rings have to be a complete solution to these problems.
The prevailing techniques that are now used throughout the world, when not resorting to a full valve replacement, generally employ a stabilizing annuloplasty ring for the repair that will likely reduce the circumference of the valve. This is usually accomplished by suturing into place an elastic, semi-rigid or rigid ring that is about equal to or smaller than the circumference of the native annulus being reduced; the ring may have a closed shape or be open, e.g. a C-shape. Installation takes place using regular sutures, in much the same manner as when a full valve replacement is carried out, and the procedure may consume as much time as a full valve replacement, for example, an average of about 25 to 35 minutes. Accordingly, improved annuloplasty systems and methods of reducing this time of surgery have continued to be sought.
More recently, there have been proposals to reduce the circumference of the incompetent valve by placing a series of sutures in the tissue that would gather and constrict the tissue, as shown, for example, in U.S. Pat. No. 5,593,424. There have been other proposals to insert a series of staple-like plication bands in the tissue at the perimeter of the valve, which individual plication bands are interconnected in some manner by linkage constructs, such as a filament or a band which is threaded through a passageway in a bridge region of the plication band, as shown in U.S. Pat. No. 6,702,826. Other proposals would use a series of tethered clips that are individually implanted along the perimeter of the incompetent valve before the tether is manipulated to cinch it within the clips and circumferentially tighten the valve annulus as shown in U.S. Pat. No. 6,986,775. U.S. Pat. No. 7,004,958 proposes inserting shape-memory staples through the wall of the coronary sinus and into the wall of the mitral valve; the staples pierce and gather up the mitral valve annulus tissue to tighten the mitral valve annulus. In U.S. Pat. No. 7,037,334, there is a proposal for a catheter-based annuloplasty through the implantation of a series of local plications which individually gather a portion of the tissue; shape-memory metallic elements that will return to a state which causes tissue located between initially spaced apart legs to be gathered or pinched together in order to constrict an incompetent valve annulus. U.S. Pat. No. 7,485,142 shows the use of a plurality of individual linkers that have anchors for implantation into heart valve tissue which carry upstanding posts having arms to connect with an adjacent post. The arms are formed of shape-memory material and shrink in length to constrict the heart valve tissue.
A hernia is one of the most common ailments of mankind; approximately five percent of the adult male population is affected. Basically, a hernia is a weakness or hole in the abdominal wall through which abdominal contents such as bowels may protrude. The surgical repair of an inguinal hernia, (i.e. inguinal herniorrhaphy) and repair of abdominal wall hernia are among the most common procedures performed, generally on an outpatient basis. Five hundred thousand inguinal herniorrhaphies and about one hundred and eight thousand abdominal herniorrhaphies may be performed each year in the United States. In the case of abdominal wall repair, whether done openly or laparoscopically, the procedure is such that an anesthetic is first administered to the patient, and the surgeon then makes the relevant incisions in the patient's abdominal wall. Supporting abdominal muscles and fascia are dissected to reveal the hernia sac, and the herniated contents protruding through the opening in the abdominal wall are returned to the abdomen. Thereafter, the surgeon closes the hernia sac either primarily or using a supporting artificial mesh implant. The local tissues are then sutured together from opposite sides of the weakened tissue, hole or hernia.
Stretched or otherwise weakened tissue may be cut away, and a patch of artificial material is often sutured or stapled to the normal tissue to replace the stretched or otherwise weakened tissue or to reinforce over the outside or inside of the repair. The incision is then closed over the repair. Recovery time necessary prior to heavy lifting or strenuous labor is usually six to eight weeks. Examples of such repair are seen in U.S. Pat. Nos. 4,347,847 and 5,122,155.
None of the foregoing proposals as practices has yet been considered to provide a completely favorable solution to these problems of incompetent valves and of efficient and satisfactory hernia repair; thus, the search for better solutions has continued.